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NCT Number: NCT07475962

Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes

The goal of this observational cross-sectional study is to assess the prevalence and stage of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis in adults aged 18 and older living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec.

The main questions it aims to answer are:

1. What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec? 2. Are there patients with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices?

Researchers will compare three participant subgroups based on adiposity (a control group without increased adiposity, an overweight group with increased adiposity, and an obesity group with increased adiposity) to see if the prevalence and severity of hepatic steatosis and fibrosis are highest in the obesity group and lowest in the control group. They will also explore if variables and potential risk factors associated with liver disease differ across these subgroups.

Participants will attend a single study visit where they will be asked to:

* Provide clinical data through laboratory analyses. * Undergo specific clinical procedures. * Complete validated questionnaires.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders Immune System Diseases Latent Autoimmune Diabetes in Adult (LADA) Liver Cirrhosis Liver Diseases Liver Fibrosis Liver Steatoses MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals ≥ 18 years of age.
  • A clinical diagnosis of type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).

Exclusion criteria

  • Alcohol consumption exceeding 20g per day in women or 30g per day in men.
  • Known chronic liver disease (including viral, drug-induced, Wilson disease, deficit in alpha-1-antirypsin, hemochromatosis, autoimmune hepatitis, etc.).
  • Evidence of cirrhosis based on a result of liver biopsy, or history of portal hypertension presented by ascites, hepatic encephalopathy or varices.
  • History of use of medications known to induce liver steatosis, including corticosteroids, high-dose estrogens, tamoxifen, methotrexate, amiodarone, or tetracycline.
  • Ongoing pregnancy.
  • Life expectancy of less than 5 years, as per investigators' clinical judgment.

Treatment and study plan

Adiposity and BMI Classification

Other

Participants are classified into three subgroups based on their BMI and the presence of increased adiposity. Increased adiposity is defined by waist circumference, waist-to-hip ratio, or waist-to-height ratio exceeding sex- and ethnicity-specific thresholds. The subgroups are: a control group (no increased adiposity), an overweight group (BMI 25.0-29.9 kg/m² with increased adiposity), and an obesity group (BMI ≥ 30 kg/m² with increased adiposity).

Primary outcomes

  1. Assessment of liver fibrosis using FibroScan

    Time frame: Baseline (Day 1 / Single Study Visit)

    Liver fibrosis severity will be quantified using liver stiffness measurement (LSM) obtained via FibroScan. The measurement is expressed in kilopascals (kPa). Higher values indicate more severe fibrosis, categorized as: < 8.0 kPa (Normal), 8.0 to 9.6 kPa (Significant fibrosis), 9.7 to 13.5 kPa (Advanced fibrosis), and > 13.5 kPa (Cirrhosis)

  2. Degree of liver steatosis assessment

    Time frame: Baseline (Day 1 / Single Study Visit)

    Liver steatosis will be quantified using the Controlled Attenuation Parameter CAP value generated simultaneously during the FibroScan assessment. The measurement is expressed in decibels per meter (dB/m). Higher values indicate a higher degree of steatosis, categorized as: < 294 dB/m (<5% steatosis), 294 to 310 dB/m (5 to 30%), 311 to 330 dB/m (30 to 60%), and > 330 dB/m (>60%).

Secondary outcomes

  1. Anthropometric Assessment: Body mass Index (BMI)

    Time frame: Baseline (Day 1 / Single Study Visit)

    Body mass index (BMI: kg/m^2) will be calculated using weight (kg) and height (cm) to compare FibroScan results across predefined subgroups.

  2. Anthropometric Assessment: Waist circumference

    Time frame: Baseline (Day 1 / Single Study Visit)

    Waist circumference and hip circumference (cm) will be used to compare FibroScan results across predefined subgroups.

  3. Adiposity-Based Subgroup Classification

    Time frame: Baseline (Day 1 / Single Study Visit)

    Participants will be categorized into three groups (e.g., Low, Medium, High adiposity) based on a composite of iDXA

Other outcomes

  1. Alcohol Use Disorders Identification Test (AUDIT) Score

    Time frame: Baseline (Day 1 / Single Study Visit)

    Total score from the 10-item AUDIT questionnaire to assess alcohol consumption. Range: 0 to 40. A higher score indicates a greater risk of hazardous and harmful alcohol use, as well as potential alcohol dependence (A score of 8 or more is typically considered the threshold for hazardous drinking).

  2. Physical Activity Level (IPAQ)

    Time frame: Baseline (Day 1 / Single Study Visit)

    Total physical activity expressed as Metabolic Equivalent of Task (MET)-minutes per week. A higher score (higher MET-minutes/week) indicates a higher level of physical activity.

  3. Eating Behavior (Three-Factor Eating Questionnaire: TFEQ)

    Time frame: Baseline (Day 1 / Single Study Visit)

    The TFEQ-R18 is an 18-item validated tool used to assess three domains of eating behavior: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Raw scores are transformed to a 0-100 scale. For all sub-scales, higher scores indicate a greater presence of that specific eating behavior (e.g., higher emotional eating or higher restraint).

  4. Dietary Intake (RxFood Diary)

    Time frame: Baseline (Day 1 / Single Study Visit)

    Average daily caloric intake calculated over 3 days

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie Parent

CONTACT

[email protected]

Élisabeth Nguyen, DtP, M.Sc

CONTACT

[email protected]

(514) 987-5617

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Acronym: STEA-DT1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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